Bipolar Head

Basic Information

• Brand Name: Bipolar Head
• Primary DI: 08033390032148
• Version / Model: Femoral Head Gauge
• Catalog Number: 9050.10.001
• Company Name: LIMACORPORATE SPA
• Labeler DUNS: 432066322
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-17
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 78cdf812-4ea8-4014-a690-5d71c3472f36

Device Description

Femoral Head Gauge Dia.41-45mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	888.3358	2
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	888.3310	2
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	888.3390	2
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	888.3350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46479	Surgical implant template, reusable	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033390032148	GS1

Premarket Submissions

Submission Number	Supplement Number
K112158	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Dia.41-45mm